The Dutch Acute Stroke Trial (DUST): Prediction of Outcome With Computed Tomography (CT) - Perfusion and CT-angiography

NCT ID: NCT00880113

Last Updated: 2012-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Brief Summary

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Less than 10% of all ischemic stroke patients are treated by intravenous thrombolysis (IVT) as most present later than the accepted 3 hour time window. Intra-arterial thrombolysis (IAT) is possible 3-6 hours post ictus, but is infrequently used. Mechanical thrombectomy (MT) with a MERCI device is a new intervention possibility but lacks large randomized studies. Although it is desirable to treat more stroke patients, clinical information and plain CT alone are insufficient to discriminate which patients are most likely to benefit or be harmed from treatment. Advanced imaging techniques can help predict patient outcome and provide the necessary information to weigh expected benefit against associated risk of treatment. Visualizing the penumbra, the hypoperfused tissue at risk of infarction around the irreversible infarct core, is one way of identifying patients most likely to benefit from intervention. Magnetic resonance imaging (MRI) based selection of patients with sufficient penumbra for thrombolysis is possible, however, MR has less 24-hour availability than CT in the acute setting. Plain CT is mostly used to exclude intracerebral hemorrhage, and can easily be extended with CT perfusion (CTP) and CT angiography (CTA). CTP compares well to MRI for imaging penumbra and infarct core, and it is faster and more feasible than MRI. Other image findings such as infarct core size and leakage of the blood-brain-barrier (permeability) on CTP, and site and extent of the occlusion and collateral circulation on CTA also influence stroke outcome but have not been combined in one study to assess their combined predictive value.

Hypothesis:

The investigators hypothesize that combined CTP and CTA parameters can predict patient outcome in acute ischemic stroke.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute stroke

Patients over 18 years of age with acute stroke symptoms of less then 9 hours duration and no hemorrhage on non-contrast CT.

Non-contrast CT, CT-perfusion and CT-angiography

Intervention Type PROCEDURE

Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).

Interventions

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Non-contrast CT, CT-perfusion and CT-angiography

Included patients will undergo one additional combined CT-scan (NCCT, CTP and CTA) on day 3 (+/- 2 days).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute neurological deficit caused by cerebral ischaemia
* Admission \< 9 hours after onset of neurological deficit
* NIH Stroke Scale (NIHSS) of at least 2
* No absolute contraindications against intravenous contrast
* Informed consent from patient or family after admission scan
* Patients who awaken with stroke symptoms can only be included if they went to sleep without any stroke symptoms and the time from going to sleep until imaging is less than 9 hours

Exclusion Criteria

* Neurological deficit caused by another diagnosis than cerebral ischaemia (such as intracerebral hemorrhage, subarachnoid hemorrhage or tumor)
* Patients with known contrast allergy or kidney failure
* Patients with the known combination of renal insufficiency and heart failure (New York Heart Association (NYHA) IV) will be excluded for the CTP and CTA scan at 3 days; they will have a non-contrast CT (NCCT) at that time.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dutch Heart Foundation

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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University Medical Center Utrecht

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, , Netherlands

Site Status RECRUITING

VU Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Gelre Hospitals

Apeldoorn, , Netherlands

Site Status RECRUITING

Alysis Zorggroep

Arnhem, , Netherlands

Site Status RECRUITING

Catharina Hospital

Eindhoven, , Netherlands

Site Status RECRUITING

Leiden University Medical Center

Leiden, , Netherlands

Site Status RECRUITING

St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status RECRUITING

UMC St. Radboud

Nijmegen, , Netherlands

Site Status RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status RECRUITING

St. Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status RECRUITING

Medical Center Haaglanden, location Westeinde

The Hague, , Netherlands

Site Status RECRUITING

St. Elisabeth Hospital

Tilburg, , Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Tom van Seeters, MD

Role: CONTACT

0031887553252

References

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Dankbaar JW, Horsch AD, van den Hoven AF, Kappelle LJ, van der Schaaf IC, van Seeters T, Velthuis BK; DUST Investigators. Prediction of Clinical Outcome After Acute Ischemic Stroke: The Value of Repeated Noncontrast Computed Tomography, Computed Tomographic Angiography, and Computed Tomographic Perfusion. Stroke. 2017 Sep;48(9):2593-2596. doi: 10.1161/STROKEAHA.117.017835. Epub 2017 Jul 17.

Reference Type DERIVED
PMID: 28716981 (View on PubMed)

Luitse MJ, Velthuis BK, Kappelle LJ, van der Graaf Y, Biessels GJ; DUST Study Group. Chronic hyperglycemia is related to poor functional outcome after acute ischemic stroke. Int J Stroke. 2017 Feb;12(2):180-186. doi: 10.1177/1747493016676619. Epub 2016 Oct 26.

Reference Type DERIVED
PMID: 27784821 (View on PubMed)

van den Wijngaard IR, Wermer MJ, Boiten J, Algra A, Holswilder G, Meijer FJ, Dippel DW, Velthuis BK, Majoie CB, van Walderveen MA. Cortical Venous Filling on Dynamic Computed Tomographic Angiography: A Novel Predictor of Clinical Outcome in Patients With Acute Middle Cerebral Artery Stroke. Stroke. 2016 Mar;47(3):762-7. doi: 10.1161/STROKEAHA.115.012279. Epub 2016 Jan 26.

Reference Type DERIVED
PMID: 26814234 (View on PubMed)

van den Wijngaard IR, Boiten J, Holswilder G, Algra A, Dippel DW, Velthuis BK, Wermer MJ, van Walderveen MA. Impact of Collateral Status Evaluated by Dynamic Computed Tomographic Angiography on Clinical Outcome in Patients With Ischemic Stroke. Stroke. 2015 Dec;46(12):3398-404. doi: 10.1161/STROKEAHA.115.010354. Epub 2015 Nov 5.

Reference Type DERIVED
PMID: 26542691 (View on PubMed)

Bennink E, Oosterbroek J, Horsch AD, Dankbaar JW, Velthuis BK, Viergever MA, de Jong HW. Influence of Thin Slice Reconstruction on CT Brain Perfusion Analysis. PLoS One. 2015 Sep 11;10(9):e0137766. doi: 10.1371/journal.pone.0137766. eCollection 2015.

Reference Type DERIVED
PMID: 26361391 (View on PubMed)

Luitse MJ, Velthuis BK, Dauwan M, Dankbaar JW, Biessels GJ, Kappelle LJ; Dutch Acute Stroke Study Group. Residual high-grade stenosis after recanalization of extracranial carotid occlusion in acute ischemic stroke. Stroke. 2015 Jan;46(1):12-5. doi: 10.1161/STROKEAHA.114.007169. Epub 2014 Dec 9.

Reference Type DERIVED
PMID: 25492908 (View on PubMed)

Fahmi F, Marquering HA, Borst J, Streekstra GJ, Beenen LF, Niesten JM, Velthuis BK, Majoie CB, vanBavel E; DUST study. 3D movement correction of CT brain perfusion image data of patients with acute ischemic stroke. Neuroradiology. 2014 Jun;56(6):445-52. doi: 10.1007/s00234-014-1358-7. Epub 2014 Apr 9.

Reference Type DERIVED
PMID: 24715201 (View on PubMed)

Other Identifiers

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NL25625.041.08

Identifier Type: -

Identifier Source: secondary_id

2008T034

Identifier Type: -

Identifier Source: org_study_id

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